The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.

Device Description

The Flexipet® Denuding Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 120 µm to 170 µm on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.

The Flexipet® Manipulation Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 80 um to 600 um on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Acceptance Criteria	Reported Device Performance
MEA (Mouse Embryo Assay)	≥80% 1-cell embryos developed to blastocyst within 96 hours.	The predetermined acceptance criterion was met.
LAL (Limulus Amebocyte Lysate)	< 20 EU/device	The predetermined acceptance criterion was met.
Cytotoxicity	All test extracts must have a reaction grade of less than 2 (mild reactivity).	The predetermined acceptance criterion was met.
Accelerated Aging	Devices remained flexible and did not become brittle after sterilization and accelerated aging.	The acceptance criterion was met.
Pull-Out Force	Minimum of 0.4 lbf required to pull the pipette out of the aspiration tool.	The predetermined acceptance criterion was met. (Results showed it was met)
Aspiration Test	Fluid was aspirated through the Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes using the Cook Flexipet® Adjustable Handle.	The acceptance criterion was met.

2. Sample size used for the test set and the data provenance:

MEA Testing: The document refers to "lot-release Mouse Embryo Assay testing," implying that samples from manufacturing lots were tested. The specific sample size (number of embryos or pipettes tested per lot) is not provided.
LAL Testing: Similar to MEA, "lot-release tested" implies samples from manufacturing lots. The specific sample size is not provided.
Cytotoxicity Testing: The number of devices or test extracts used is not specified.
Accelerated Aging: The number of devices subjected to accelerated aging is not specified.
Pull-Out Force Testing: The number of pipettes tested is not specified.
Aspiration Test: The number of pipettes tested is not specified.

The data provenance is not explicitly stated. Given that these are release tests for a manufactured device, it is presumed to be prospective testing carried out by the manufacturer (Cook Incorporated) at their facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document describes performance testing for a medical device (pipettes), not an AI algorithm that requires expert-established ground truth. Therefore, this information is not applicable. The "ground truth" for these tests are objective, measurable criteria (e.g., embryo development percentage, endotoxin levels, reaction grades, force measurements, successful fluid aspiration).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable as the tests described are objective, quantitative or semi-quantitative laboratory tests without a need for expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The document describes performance testing for physical pipettes, not an AI algorithm.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The document describes performance testing for physical pipettes, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests described are objective, pre-defined measurable outcomes based on biological (e.g., embryo development, cytotoxicity), chemical (e.g., LAL endotoxin), and physical (e.g., force, flexibility, aspiration) properties and performance specifications of the device.

8. The sample size for the training set:

This is not applicable. This document describes performance testing for physical pipettes, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable. This document describes performance testing for physical pipettes, not an AI algorithm that requires a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2015

Cook Incorporated Naomi Funkhouser Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Re: K150748

Trade/Device Name: Flexipet® Denuding Pipette, Flexipet® Manipulation Pipette Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: Class II Product Code: MOH Dated: November 18, 2015 Received: November 18, 2015

Dear Naomi Funkhouser,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150748

Device Name

Flexipet® Denuding Pipette and Flexipet® Manipulation Pipette

Indications for Use (Describe)

The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, occyte and embryo manipulation, or denuding.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below it.

COOK INCORPORA NIELS WAY, P.O.

5.0 510(k) Summary

Flexipet® Denuding Pipette Flexipet® Manipulation Pipette 510(k) Summary 21 CFR §884.6130 Date Prepared: December 11, 2015

Cook Incorporated

750 Daniels Way

P.O. Box 489

Submitted By:

Applicant:
Address:

Phone Number: Fax Number:

Contact: Contact Address:

Contact Phone Number: Contact Fax Number:

(812) 335-3575 x104371 (812) 332-0281 Naomi Funkhouser Cook Incorporated 750 Daniels Way

Bloomington, IN 47402

P.O. Box 489 Bloomington, IN 47402 (812) 335-3575 x104371 (812) 332-0281

Device Information:

Trade name: Common name:

Classification Name:

Regulation: Product Code: Flexipet® Denuding Pipette Flexipet® Manipulation Pipette Microtools, Assisted Reproduction (Pipettes) Assisted Reproduction Microtools. 21 CFR §884.6130 MOH

Predicate Device:

The predicate device is "THE STRIPPER®" Micropipetter and Micropipetter Tips (Mid-Atlantic Diagnostics, Inc., K993699).

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in white, and both words are set against a red background.

Device Description:

Intended Use:

The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, or denuding.

Comparison to Predicates:

The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes are substantially equivalent to the predicate device, "THE STRIPPER®" Micropipetter and Micropipetter Tips (Mid-Atlantic Diagnostics, Inc., K993699), in that these devices have similar designs, methods of construction and operation, and indications for use.

Technological Characteristics:

The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes were subjected to testing as to assure validation of design and performance.

1. MEA Testing The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes underwent lot-release Mouse Embryo Assay testing. The acceptance criterion was that ≥80% 1-cell embryos developed to blastocyst within 96 hours. The predetermined acceptance criterion was met.
1. LAL Testing The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes were lot-release tested using the Limulus Amebocyte Lysate (LAL) test. The devices must demonstrate < 20 EU/device. The predetermined acceptance criterion was met.

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Image /page/5/Picture/0 description: The image is a logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below that, the word "MEDICAL" is written in white letters on a black background.

1. Cytotoxicity Testing Testing was performed with the requirement that all test extracts must have a reaction grade of less than 2 (mild reactivity). The results showed that the predetermined acceptance criterion was met.
1. Accelerated Aging After sterilization and accelerated aging, the devices remained flexible and did not become brittle; therefore, the acceptance criterion was met.
1. Pull-Out Force Testing was performed with the requirement that the force needed to pull the pipette out of the aspiration tool must be a minimum of 0.4 lbf. The results showed that the predetermined acceptance criterion was met.
1. Aspiration Test Fluid was aspirated through the Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes using the Cook Flexipet® Adjustable Handle. The acceptance criterion was met.

Conclusion:

The results of these tests support a conclusion that the Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes met the design input requirements based on the intended use and support the conclusion that these devices do not raise new questions of safety or effectiveness as compared to, and are substantially equivalent to, the predicate device, "THE STRIPPER® Micropipetter and Micropipetter Tips, manufactured by Mid-Atlantic Diagnostics, Inc., cleared under 510(k) Premarket Notification Number K993699 on May 16, 2000.

Regulation Number and Section

§ 884.6130 Assisted reproduction microtools.

(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.